1. Field of the Invention
The present invention relates generally to devices and methods of treating respiratory tract disorders. Particularly, the present invention relates to the treatment of obstructive pulmonary disease. More particularly, the present invention relates to the treatment of obstructive pulmonary disease with topical controller medications and topical rescue medications as a regimen where the dosage of one medication is a determinant for the need for the other medication in a particular individual.
2. Description of the Prior Art
Obstructive lung diseases are diseases that are characterized by narrowing and inflammation of the bronchial air flow tract. Asthma is an example of an obstructive respiratory tract disorder. Symptoms consist of coughing, excessive sputum productions, wheezing, and shortness of breath. Symptoms typically vary in severity over time and, of the obstructive respiratory disorders, changes in severity are most prominent and rapidly occurring with asthma.
Obstructive lung diseases are generally chronic and require long-term treatment. One approach to treatment is directed at preventing symptoms. Medications used for this purpose are referred to as “preventative” or “controller” therapy. In the event that symptoms flare despite the use of controller therapy, it becomes necessary to utilize medication to bring about immediate relief. Medications used for this purpose are often referred to as “rescue” medications.
Adrenergic agonists are commonly used to reverse bronchial tree spasm occurring with obstructive pulmonary disorders. Both long-acting and short-acting forms are available. Long-acting forms are often employed when such agents are used to prevent symptoms. An example of a long-acting agent is the selective beta2-adrenergic bronchodilator known as salmeterol xinafoate and marketed under the trademark Serevent®. It is used both as an inhaled dry powder aerosol and as an aerosolizable liquid in a metered dose inhaler.
In the event of a breakthrough of symptoms, it is preferable not to use additional doses of long-acting adrenergic agents for concern of accumulation of medication. Adrenergic agents have adrenalin-like effects such as nervousness and rapid heart beat. Accumulation or overdose of such medication can have potentially dangerous consequences such as irregularities of the heart rhythm. An adrenergic agent with an immediate effect and short duration of action is therefore preferred for relief of acute symptomatic breakthrough. An example of such an adrenergic agent is albuterol USP, which is an aerosolizable liquid in a metered dose inhaler marketed under the trademark Ventolin®.
Corticosteroids are another type of medication that can be used as controller medication. Corticosteroids do not have immediate effects on symptoms, but rather reduce inflammation over a longer term. Examples of aerosolized forms of such agents are fluticasone propionate that is marketed as an inhaled powder aerosol under the trademark Flovent®, and beclomethasone dipropionate USP, which is marketed under the trademark Beclovent®, an MDI. The administration of such medications by aerosol allows them to be directed topically to the site of inflammation within the bronchial tree and has the advantage of minimizing systemic effects that are more likely to occur with oral or other systemic administration. Even administered topically, however, some systemic absorption (hypercorticism) and adrenal suppression may occur, particularly at higher doses. Because these medications are often required over long periods, they pose cumulative risks. In children, growth suppression is of particular concern and, in adults, reduction in bone density is a problem. Such agents are best employed judiciously for therapeutic benefit while avoiding overuse and side-effects.
Many drugs are utilized by patients over a period of time in varying amounts and in varying order to provide for their effective administration. Packaging has been developed for aiding the user of such drugs to comply with the proper administration over the proper time period. The dispensing apparatus associated with such multiple-day administrative drugs are typically directed to the administration of pills or capsules, or similar solid medication.
U.S. Pat. No. 4,039,080, for example, discloses a tray having individual compartments for pills that may contain a week's medication with indicia indicating the day of the week and time of the day the medication is to be taken.
U.S. Pat. No. 4,553,670 discloses another device comprising a support on which are located two different ingestible medicinal substances in a single dose form with an adjacent portion for instructional information.
U.S. Pat. No. 4,593,819 discloses a covered pill tray of rectangular configuration having an array of open-topped compartments to hold a supply of medication arranged by the day and time of taking the medication.
U.S. Pat. No. 4,736,849 discloses a method and another type of dispenser for the storage and dispensing of calendar-oriented pills.
U.S. Pat. No. 5,181,189 discloses a device for storage and time-regulated dispensing of drugs which includes a drug container to which is secured a signal generator.
U.S. Pat. No. 5,377,841 discloses a sleep therapy package which includes an audio recording of program material for inducing sleep, a card having a plurality of doses, some of which are medicine for inducing sleep and at least one of which is a placebo, along with patient instructions.
Cartonless packaging systems for containing liquids used, for example, as ophthalmic products, which also contain means for storing tablets and instructional material are disclosed in U.S. Pat. Nos. 5,489,026 and 5,489,027.
U.S. Pat. No. 5,830,490 discloses a device and method for a lay person to organize topical medications together with oral medications.
U.S. Pat. Nos. 5,941,241 and 6,382,205 disclose a device and method for a lay person to organize combined topical medication regimens.
What is not specifically described in the aforementioned inventions is the provision of topical controller medications and topical rescue medications for the treatment of obstructive pulmonary diseases and their instruction as a regimen where the dosage of one medication is a determinant for the need for the other medication in a particular individual. Controller and rescue medications for obstructive lung disorders are presently provided separately to patients. This introduces the potential for users: (a) not having one or the other medication due to its not being prescribed or being overlooked, (b) overusing one of the agents if the other is unavailable, (c) being confused in identifying the agents, and/or, (d) being unsure of how to coordinate the medications together. This also introduces the potential for caregiver confusion in assessing the relative use of the individually prescribed and filled medications or even knowing with certainty if one is being filled by the patient and not the other.
Therefore, what is needed is treatment kit that reduces the likelihood of having only one of the controller or rescue medications. What is also needed is a treatment kit that reduces the likelihood of overuse of one of the medications by the patient. What is further needed is a treatment kit that reduces the likelihood of a patient confusing one medication for the other. What is still further needed is a treatment kit that reduces the likelihood of confusion over the coordination of treatment medications together as a regimen.